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The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population

Primary Purpose

Asthma, Bronchial

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma, Bronchial focused on measuring aquatic exercise, asthma

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Medically diagnosed and medication managed asthmatics between the ages of 18-40

Exclusion Criteria:

  • outside the age range of 18-40 years old, fear of water, diseases or conditions listed during screening process, or current smoker.

Sites / Locations

  • Washington State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Aquatic based exercise

Outcomes

Primary Outcome Measures

Pulmonary Function

Secondary Outcome Measures

Demographic information
Medical history
Smoking practices
Exercise practices
State Anxiety
Perceived Stress
Depression
Sleep - duration and quality
Quality of Life as related to asthma
Body composition
Cardiovascular fitness level- VO2 max
Resting Heart Rate
Heart Rate Variability and ECG
Serum cholesterol levels
Fasting blood glucose
Cortisol
Insulin
CRP
Homocysteine
Lipoprotein-Associated Phospholipase A2 (PLAC)
Medication usage
Exercise Adherence
Resting blood pressure

Full Information

First Posted
January 16, 2009
Last Updated
December 31, 2011
Sponsor
Washington State University
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1. Study Identification

Unique Protocol Identification Number
NCT00825903
Brief Title
The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population
Official Title
The Effects of Exercise on Physiological and Psychological Parameters in an Asthmatic Population
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Exercise has been shown to have extensive health benefits both in normally functioning adults as well as in adults with asthma. A program of regular aquatic exercise may have unique benefits in the asthmatic population because of the known aerobic capacity development typical of such programs, combined with the unique value of immersion-produced improvements in respiratory endurance and cardiac output. The purpose of this study is to explore the effects of a 12 week long aquatic endurance training program on several physiological and psychological parameters related to coronary heart disease and type II diabetes in an asthmatic population.
Detailed Description
The study will run from August 2008 to May 2009. Recruitment and screening of participants will occur from August to December 2008 for inclusion into the clinical trial. Prior to the clinical trial participants will have a one hour informational session to clearly present the study, obtain signed informed consent and set up fitness/blood appointments for data collection. Data collection will begin the first week of school in January. The 12-week exercise protocol will start the second week of school and continue through the middle of April. Research participants will not have any exercise session during spring break (March 16-20). Final data collection will occur during the last two weeks of school. Pre-treatment and post-treatment data collection will include a fitness assessment and blood draw. Medication usage for asthma will be monitored on a weekly basis thoughout the clinical trial. Physical activity will also be monitored monthly. The screening session is a 30-minute session where research participants complete health/behavior questionnaires and a physiological measure of lung function. Information to be collected in the health/behavior questionnaires includes: demographic and behavioral/lifestyle variables (sex, race, age, smoking status, and medical history). The fitness assessment will be 60 minutes in length. At the beginning of the session participants will complete a survey to assess state anxiety (State-Trait Anxiety Inventory - Trait version Form X-1; Spielberger, Gorsuch, & Lushene, 1970). Heart rate variability will be measured through the ventral placement of 3 electrodes placed on the subject's torso. The areas will be prepped by swabbing with alcohol and lightly scrubbing to remove dead skin. The electrodes will be held in place with a sticky disc and a strip of athletic tape. Heart rate and resting blood pressure will also be taken. Body composition will be assessed using the BodPod system. Research participants will sit in an enclosed capsule (bod pod) for three tests lasting approximately 40 seconds each. Lung function will be assessed using a spirometer to measure the maximal volume of air exhaled over a period of time after a maximal inhalation. To assess cardiorespiratory fitness research participants will complete a VO2 Max test. Participants will ride a bicycle ergometer for approximately 15-20 minutes moving through stages (including a 3 minute warm-up) with progressively higher resistance levels until maximum tolerance. After termination there is a cool-down/recovery period of approximately 3-4 minutes. The blood draw session will take approximately 30 minutes and participants will be asked to fast (no food or drink) for 12 hours prior to blood draw. Upon check-in participants will complete a series of questionnaires assessing psychological variables stress (Perceived Stress Scale-14 item version Form X-1; Cohen, Kamarck & Mermelstein, 1983), depression (Center for Epidemiological Studies - Depression Scale; Radloff, 1977), and quality of life (Asthma Impact Survey; QualityMetric Health Outcomes Solutions, Lincoln, RI). The quality and quantity of sleep will also be assessed using the Pittsburgh Sleep Quality Index (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989). Once questionnnaires are completed, participants will have their blood drawn by a certified phlebotomist. Three days after the blood draw particpants will be contacted by phone and questioned about current health status. After the first week of pretreatment data collection, before the training sessions begin, research participants will undergo an explanation and training session to learn how to evaluate their own rate of perceived exertion (RPE). The water-based exercise programs are 3 times a week for 12 weeks. The exercise sessions will begin with a 10-minute warm up and end with a 5-minute cool down period. The conditioning portion of the exercise program will be shorter in duration with lower intensities at the beginning of the 12 weeks. There will be a progression to higher intensities for longer periods of time throughout the 12 weeks using recommendations from the American College of Sports Medicine. Exercise sessions will not exceed 50 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Bronchial
Keywords
aquatic exercise, asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Aquatic based exercise
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Exercise 3 times each week for a total of 12 weeks. Each session is 50 min. in length.
Primary Outcome Measure Information:
Title
Pulmonary Function
Time Frame
baseline and 12 weeks post
Secondary Outcome Measure Information:
Title
Demographic information
Time Frame
baseline
Title
Medical history
Time Frame
baseline
Title
Smoking practices
Time Frame
baseline
Title
Exercise practices
Time Frame
baseline and monthly
Title
State Anxiety
Time Frame
baseline and 12 weeks post
Title
Perceived Stress
Time Frame
baseline and 12 weeks post
Title
Depression
Time Frame
baseline and 12 weeks post
Title
Sleep - duration and quality
Time Frame
baseline and 12 weeks post
Title
Quality of Life as related to asthma
Time Frame
baseline and 12 weeks post
Title
Body composition
Time Frame
baseline and 12 weeks post
Title
Cardiovascular fitness level- VO2 max
Time Frame
baseline and 12 weeks post
Title
Resting Heart Rate
Time Frame
baseline and 12 weeks post
Title
Heart Rate Variability and ECG
Time Frame
baseline and 12 weeks post
Title
Serum cholesterol levels
Time Frame
baseline and 12 weeks post
Title
Fasting blood glucose
Time Frame
baseline and 12 weeks post
Title
Cortisol
Time Frame
baseline and 12 weeks post
Title
Insulin
Time Frame
baseline and 12 weeks post
Title
CRP
Time Frame
baseline and 12 weeks post
Title
Homocysteine
Time Frame
baseline and 12 weeks post
Title
Lipoprotein-Associated Phospholipase A2 (PLAC)
Time Frame
baseline and 12 weeks post
Title
Medication usage
Time Frame
prior and throughout study
Title
Exercise Adherence
Time Frame
throughout study
Title
Resting blood pressure
Time Frame
baseline and 12 weeks post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Medically diagnosed and medication managed asthmatics between the ages of 18-40 Exclusion Criteria: outside the age range of 18-40 years old, fear of water, diseases or conditions listed during screening process, or current smoker.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kasee J Hildenbrand, PhD
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington State University
City
Pullman
State/Province
Washington
ZIP/Postal Code
99164
Country
United States

12. IPD Sharing Statement

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